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Can a Once-Daily eye drop ease pain and swelling after cataract surgery?

NCT ID NCT06128369

Symptom relief Sponsor: Oculis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial tests whether OCS-01, a dexamethasone eye drop, can reduce inflammation and pain after cataract surgery. About 117 adults scheduled for cataract removal will receive either the active drop or a placebo once daily. The study measures how well the drop clears eye inflammation and relieves pain in the weeks after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a dexamethasone eye drop formulation called OCS-01
What this could lead to
If effective, OCS-01 could offer a once-daily eye drop option to manage post-cataract surgery inflammation and pain.
What could go wrong
This is a Phase 3 trial, but results may not confirm benefit over placebo. Eye drops can cause side effects like increased eye pressure or delayed healing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

117 people

The number who actually took part.

Started

Dec 2023

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye. * Have a pin-hole visual acuity (VA) without any other correction \> 20 letters (approximately 20/400) in the operative eye and \> 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 \[prior to surgery\]). Exclusion Criteria: * Have any intraocular inflammation (e.g., white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 \[prior to surgery\]) slit-lamp examination. * Have a score \> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \[prior to surgery\]) in the study eye.

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Conditions

The condition(s) this trial relates to.

cataract

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammation eye pain Postoperative cataract

Contacts and locations

Locations

  • Oculis Investigative Site

    Glendale, California, 91204, United States

  • Oculis Investigative Site

    Inglewood, California, 90301, United States

  • Oculis Investigative Site

    Newport Beach, California, 92663, United States

  • Oculis Investigative Site

    Torrance, California, 90505, United States

  • Oculis Investigative Site

    Tamarac, Florida, 33321, United States

  • Oculis Investigative Site

    Morrow, Georgia, 30260, United States

  • Oculis Investigative Site

    Northbrook, Illinois, 60062, United States

  • Oculis Investigative Site

    Indianapolis, Indiana, 46240, United States

  • Oculis Investigative Site

    Louisville, Kentucky, 40206, United States

  • Oculis Investigative Site

    Woburn, Massachusetts, 01810, United States

  • Oculis Investigative Site

    St Louis, Missouri, 63131, United States

  • Oculis Investigative Site

    Washington, Missouri, 63090, United States

  • Oculis Investigative Site

    Las Vegas, Nevada, 89145, United States

  • Oculis Investigative Site

    Elizabeth City, North Carolina, 27909, United States

  • Oculis Investigative Site

    Leland, North Carolina, 28451, United States

  • Oculis Investigative Site

    Cincinnati, Ohio, 45242, United States

  • Oculis Investigative Site

    Eugene, Oregon, 97401, United States

  • Oculis Investigative Site

    Erie, Pennsylvania, 16507, United States

  • Oculis Investigative Site

    Kingston, Pennsylvania, 18704, United States

  • Oculis Investigative Site

    Nashville, Tennessee, 37212, United States

  • Oculis Investigative Site

    Austin, Texas, 78731, United States

  • Oculis Investigative Site

    Houston, Texas, 77008, United States

  • Oculis Investigative Site

    San Antonio, Texas, 78229, United States

  • Oculis Investigative Site

    Lynchburg, Virginia, 24502, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.